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Innolitics
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Miscellaneous
Miscellaneous
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
LTB
Cyclosporine Radioimmunoassay
2
Product Code
MAR
Cyclosporine And Metabolites Serum Assay
2
Product Code
MGS
High Performance Liquid Chromatography For Cyclosporine
2
Product Code
MGU
Fluorescence Polarization Immunoassay For Cyclosporine
2
Product Code
MGV
Radioimmunoassay For Cyclosporine
2
Product Code
MKW
Cyclosporine
2
Product Code
MLM
Enzyme Immunoassay, Tracrolimus
2
Product Code
NFX
Test, Cholesterol, Total, Over The Counter
1
Product Code
NFZ
Test, Creatinine, Over The Counter
2
Product Code
NGA
Test, Follicle Stimulating Hormone (Fsh), Over The Counter
1
Product Code
NGD
Test, Lactic Acid, Over The Counter
1
Product Code
NGE
Test, Luteinizing Hormone (Lh), Over The Counter
1
Product Code
NGJ
Test, Nitrite, Urinary, Non-Quantitative, Over The Counter
1
Product Code
NGO
Test, Triglycerides, Over The Counter
1
Product Code
PQO
Anti-Müllerian Hormone Test System
2
Product Code
K
22
1801
ADVIA Centaur® Anti-Müllerian Hormone (AMH)
2
Cleared 510(K)
K
22
3679
Access AMH
2
Cleared 510(K)
K
20
3757
Elecsys AMH
2
Cleared 510(K)
K
17
0524
Access AMH
2
Cleared 510(K)
DEN
15
0057
Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5
2
Cleared 510(K)
QKE
Immunoassay, Pregnanediol Glucuronide, Over The Counter
1
Product Code
Subpart C—Clinical Laboratory Instruments
CFR Sub-Part
Subpart D—Clinical Toxicology Test Systems
CFR Sub-Part
Subpart F—Immunological Test Systems
CFR Sub-Part
Subpart G—Manual Hematology Devices
CFR Sub-Part
Subpart H—Hematology Kits and Packages
CFR Sub-Part
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 25 January 2026 at 3:41 am
TX
/
subpart-b—clinical-chemistry-test-systems
/
PQO
/
K221801
View Source
ADVIA Centaur® Anti-Müllerian Hormone (AMH)
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
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FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Miscellaneous
Subpart B—Clinical Chemistry Test Systems
LTB
Cyclosporine Radioimmunoassay
MAR
Cyclosporine And Metabolites Serum Assay
MGS
High Performance Liquid Chromatography For Cyclosporine
MGU
Fluorescence Polarization Immunoassay For Cyclosporine
MGV
Radioimmunoassay For Cyclosporine
MKW
Cyclosporine
MLM
Enzyme Immunoassay, Tracrolimus
NFX
Test, Cholesterol, Total, Over The Counter
NFZ
Test, Creatinine, Over The Counter
NGA
Test, Follicle Stimulating Hormone (Fsh), Over The Counter
NGD
Test, Lactic Acid, Over The Counter
NGE
Test, Luteinizing Hormone (Lh), Over The Counter
NGJ
Test, Nitrite, Urinary, Non-Quantitative, Over The Counter
NGO
Test, Triglycerides, Over The Counter
PQO
Anti-Müllerian Hormone Test System
K
22
1801
ADVIA Centaur® Anti-Müllerian Hormone (AMH)
K
22
3679
Access AMH
K
20
3757
Elecsys AMH
K
17
0524
Access AMH
DEN
15
0057
Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5
QKE
Immunoassay, Pregnanediol Glucuronide, Over The Counter
Subpart C—Clinical Laboratory Instruments
Subpart D—Clinical Toxicology Test Systems
Subpart F—Immunological Test Systems
Subpart G—Manual Hematology Devices
Subpart H—Hematology Kits and Packages
Medical Genetics
Unknown
TX
/
subpart-b—clinical-chemistry-test-systems
/
PQO
/
K221801
View Source
ADVIA Centaur® Anti-Müllerian Hormone (AMH)
Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
PDF
Analyzed PDF
Loading...